Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia

NCT ID: NCT01460563

Last Updated: 2011-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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The investigators hypothesized that valproic acid will increase rocuronium requirement and MgSO4 infusion would reduce requirement of muscle relaxant in craniotomy patients preloaded with sodium valproate.

Detailed Description

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Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.

Conditions

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Cerebral Aneurysm

Keywords

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craniotomy sodium valproate rocuronium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mg_orfil

patients preloaded with sodium valproate receives MgSO4 during the craniotomy.

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

MgSO4 infusion: 50mg/kg bolus followed by continuous infusion

control_orfil

patients preloaded with sodium valproate receives 0.9% saline as placebo.

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

0.9% saline as same dose as MgSO4 as placebo

0.9% saline

Intervention Type DRUG

0.9% saline as same dose as MgSO4 as placebo

control_no orfil

patients not preloaded with sodium valproate receives 0.9% saline as placebo.

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

0.9% saline as same dose as MgSO4 as placebo

Interventions

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Magnesium Sulfate

MgSO4 infusion: 50mg/kg bolus followed by continuous infusion

Intervention Type DRUG

0.9% saline

0.9% saline as same dose as MgSO4 as placebo

Intervention Type DRUG

0.9% saline

0.9% saline as same dose as MgSO4 as placebo

Intervention Type DRUG

Other Intervention Names

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MgSO4 NaCl NaCl

Eligibility Criteria

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Inclusion Criteria

* 18- 65 years
* American society of anesthesiology physical status 1,2
* scheduled for elective craniotomy for aneurysm clipping or for superficial temporal artery-middle cerebral artery anastomosis

Exclusion Criteria

body mass index \<18.5 or \>24.9 kg m-2; neuromuscular, renal, cardiovascular or hepatic insufficiency; Glasgow coma scale (GCS) \<15; allergy to the study drugs; medications influencing NDMRs; breast feeding; pregnancy; and preoperative epilepsy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kim Mihyun

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanghwan Do, Doctor

Role: STUDY_CHAIR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang hopital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Mihyun Kim, Doctor

Role: CONTACT

Phone: 82-31-787-7499

Email: [email protected]

Facility Contacts

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Mihyun Kim, Doctor

Role: primary

Other Identifiers

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Mg_orfil

Identifier Type: -

Identifier Source: org_study_id